Subject: NIH GUIDE - V20(26) 07/26/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 24 Jul 91 13:13 EST

Hi Paul,
  This is the first of three articles coming to you this week for
the July 26, l99l NIH Guide.  Please post this one as:
     NIHGUIDE.910726
  Thanks.    Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19910726 V20N26 P1O1 ************************************
X-comment: RFAs described: HS-91-03, HS-91-02
 
NIH GUIDE - Vol. 20, No. 29, July 26, 1991
 
$$INDEX BEGIN **********************************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 10/10/91 ****************************************************
 
NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS (RFA HS-91-03)
Agency for Health Care Policy and Research
Index:  HEALTH CARE POLICY, HEALTH CARE RESEARCH
 
$$INDEX R2 11/12/91 ****************************************************
 
MEDTEP RESEARCH CENTERS ON MINORITY POPULATIONS (RFA HS-91-02)
Agency for Health Care Policy and Research
Index:  HEALTH CARE POLICY, HEALTH CARE RESEARCH

                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$INDEX P1 *************************************************************
 
ANOREXIA NERVOSA AND BULIMIA NERVOSA:  BASIC BRAIN, BEHAVIORAL, AND
CLINICAL STUDIES (PA-91-79)
National Institute of Mental Health
Index:  MENTAL HEALTH
 
$$INDEX P2 *************************************************************
 
ANTICANCER MODEL DEVELOPMENT (PA-91-80)
National Cancer Institute
Index:  CANCER

                                   ERRATUM
 
$$INDEX E1 *************************************************************
 
PROGRAM PROJECTS ON AUTOIMMUNITY (RFA AI-91-09)
National Institute of Allergy and Infectious Diseases
Index:  ALLERGY, INFECTIOUS DISEASES
 
$$INDEX END ************************************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$R1 BEGIN HS-91-03 FULL-TEXT ******************************************
 
NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS
 
RFA AVAILABLE:  HS-91-03
 
P.T. 44; K.W. 0720005, 0730050, 1004017, 0408006
 
Agency for Health Care Policy and Research
 
Application Receipt Date:  October 10, 1991
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) awards National
Research Service Award (NRSA) institutional grants (T32) to eligible
institutions to develop or enhance research training opportunities for
qualified individuals of the institution's selection who seek to prepare
for careers in health services research.  This Request for Applications
(RFA) announces the application receipt date for this program (October
10, 1991) and identifies the training areas of special interest.
 
The purpose of these awards is to assist domestic institutions in
supporting predoctoral and postdoctoral academic training.  The awards
allow trainees to gain experience in applying research methods to the
systematic analyses and evaluation of health services.  Individuals are
selected by institutions on the basis of a demonstrated interest and
relevant background in health services research.
 
MECHANISM OF SUPPORT
 
This announcement is made subject to availability of funds.  AHCPR
reserves the right to withdraw this Request for Applications if funds do
not become available.  This is a one-time announcement.  Applications
will not be accepted after October 10, 1991.  AHCPR expects to fund no
more than five new awards in response to this RFA.
 
LEVELS AND AREAS OF TRAINING
 
Applicant institutions may apply for support for predoctoral students,
postdoctoral students, or a combination.  Applicants must include a
rationale for their choice of supporting type(s) of students.  Research
training must provide the conceptual and methodological foundation for
investigating some or all of the following health care areas:  (1)
primary care issues, including development of techniques to measure the
effectiveness of managing health care conditions; (2) appropriateness
and effectiveness of alternative treatments in terms of patient outcomes
and use of services; (3) factors affecting dissemination and
assimilation of information on health care technologies and other
aspects of clinical practice; (4) alternative approaches to organizing,
financing, and reimbursing for health care services and their effects on
cost, quality, and access; (5) application of medical informatics to the
development of expert systems for treatment selection and diagnosis; (6)
practice-based research, including clinical practice variations and
guideline development; (7) medical malpractice and liability; (8)
delivery of health services to the medically underserved, especially in
rural areas; (9) availability, accessibility, and quality of care for
low-income groups, minorities, and the elderly; (10) cost-effectiveness
and cost-benefit analysis, including allocation of health care resources
and relationship to health status; (11) alternative delivery systems,
providers, and practice patterns in long-term care, including home and
community-based care; (12) organizational structure, resource use, and
costs of care for persons with HIV-related illnesses.
 
ELIGIBILITY REQUIREMENTS
 
Domestic nonprofit, private or public, institutions may apply for grants
to support research training programs.  The applicant institution must
have the staff and facilities required for the proposed program.  The
training program director at the institution will be responsible for the
selection and appointment of trainees and for the overall direction of
the program.
 
METHOD OF APPLYING
 
Applications must be made on grant application form PHS 398 (rev.
10/88).  This revision contains additional instructions for preparing
institutional National Research Service Award applications.  Completed
applications must be mailed to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
REVIEW PROCESS AND SCHEDULE
 
The NRSA training grant receipt date and review cycle for all
applications submitted in response to this RFA is indicated below.
 
Application          Initial review         Council        Earliest
receipt date         group meeting          meeting        possible
                                                           start date
 
October 10, 1991     November 1991        January 1992     March 1992
 
Applications will be reviewed by an AHCPR initial review group (IRG) and
the National Advisory Council for Health Care Policy, Research, and
Evaluation.  The IRG will consider the following criteria in its review:
the goals of the proposed training program and the probability of
achieving them; substantive content of the proposed program and its
relevance to current health care concerns, including courses offered;
qualifications and responsibilities of the program director;
qualifications of the program's faculty, including ongoing health
services research, and commitment to tracking graduates following
training; program's ability to recruit qualified trainees; commitment to
adequate space, curriculum time, financial support, and appropriate
facilities; cooperation of related agencies or organizations in
providing experience and research training sites for trainees; number
and types of students for whom support is requested; proposed methods
for monitoring and evaluating the performance of trainees as well as the
overall program; and reasonableness of the proposed budget in relation
to the proposed training.
 
In addition to the recommendations made by the IRG, the Council will
consider the applicant institution's plans for (and likely success in)
recruitment of individuals from underrepresented minority groups into
the training program.  Funding decisions will be based on the review
groups' recommendations, the need for research personnel in specified
program areas, and the availability of funds.
 
INQUIRIES
 
The AHCPR supports training in all areas of health services research.
 
Inquiries regarding this RFA and requests for a copy of the full RFA may
be directed to:
 
DonnaRae Castillo
NRSA Project Officer
Agency for Health Care Policy and Research
Parklawn Building, Room 18A-10
Rockville, MD  20857
Telephone:  (301) 443-2904
 
Information on grants management issues may be obtained from:
 
Ralph Sloat, Chief
Grants Management Branch
Agency for Health Care Policy and Research
Parklawn Building, Room 18A-27
Rockville, MD  20857
Telephone:  (301) 443-4033
 
Awards are made under authority of section 487 of the Public Health
Service (PHS) Act as amended (42 USC 288).  Title 42 of the Code of
Federal Regulations, Part 66, is applicable to this program.  The
program is described under Catalog of Federal Domestic Assistance No.
93.225.
 
$$R1 END ***************************************************************
 
$$R2 BEGIN HS-91-02 FULL-TEXT ******************************************
 
MEDTEP RESEARCH CENTERS ON MINORITY POPULATIONS
 
RFA AVAILBLE:  HS-91-02
 
P.T. 34, FF; K.W. 1004017, 0730050
 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date:  August 12, 1991
Application Receipt Date:  November 12, 1991
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) invites
applications for cooperative agreements from nonprofit organizations to
develop and manage research Centers.  The centers will conduct and
support research, technical assistance, information dissemination, and
research training on the appropriateness and effectiveness of health
care services and procedures provided to minority populations.  Support
for these research centers will be provided through the Medical
Treatment Effectiveness Program (MEDTEP) of the Department of Health and
Human Services.  The centers will be known as MEDTEP Research Centers on
Minority Populations.  For the purposes of this announcement, minority
populations are defined to include African Americans, Hispanic
Americans, American Indians, Alaska Natives, Asians, and Pacific
Islanders.  Awards are expected to be made in Fiscal Year 1992.
 
Preference will be given to applicants that currently devote a major
portion of their resources to the training of minority health care
providers, employment of minority health care providers, and provision
of health care to minority populations.  Comments on this preference are
being solicited through a separate notice on the program that is being
published in the FEDERAL REGISTER.
 
Applicants must have the scientific, technical, organizational, and
physical resources necessary to carry out:  (1) multidisciplinary
patient outcomes research; (2) technical assistance to health care
providers and others; (3) training of health services researchers; and
(4) dissemination of research findings and the evaluation of
dissemination strategies.
 
The centers are also expected to work with the AHCPR on analyses and
studies.  Such joint activities may involve syntheses of research
findings, data analyses, or the preparation of background information on
various topics relating to health care and minority populations.  As
part of a cooperative agreement, the AHCPR will also have substantive
involvement in the planning and conduct of research, technical
assistance, dissemination, and training carried out by each center.
 
HEALTHY PEOPLE 2000
 
AHCPR is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This announcement, "MEDTEP
Research Centers on Minority Populations," addresses health services and
protection objectives 21.3-21.8 and other special populations objectives
targeting minorities.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).
 
CENTER STRUCTURE AND MECHANISM OF SUPPORT
 
AHCPR funds are intended to provide basic support for each center.  Core
funding will be provided through the cooperative agreement (U01) grant
mechanism, in which the recipient is reimbursed for administrative and
staff support, the provision of technical assistance, dissemination
mechanisms such as center-sponsored newsletters, and a program of
training in patient outcomes research.  Research projects may also be
supported in their initial stages with core funds, although it is
expected that research projects will ultimately be sponsored with funds
obtained from sources other than the AHCPR cooperative agreement grant.
 
The center director will be responsible for the organization and
operation of the center; liaison with the research community and outside
entities such as professional societies, subcontractors, and consumer
groups; and communication with the AHCPR on scientific and operational
matters.  Personnel and institutional resources capable of developing
and maintaining a substantial commitment to patient outcomes research
must be available.  The center may consist of core staff with
significant time commitments to the center and affiliate staff with
lesser time commitments.
 
The center may be a consortium of organizations that will provide
collateral or supplemental support to the applicant institution.
 
A maximum of $750,000 annual total costs (direct plus indirect) may be
requested for full center support, and a maximum of $3,750,000 in total
costs may be requested per application for full centers for the entire
project period, not to exceed five years.
 
Applicants may request developmental funding of up to $400,000 total
annual costs for each of a minimum of two years and a maximum of three
years if the proposed center needs time to develop and is not likely to
meet initially all performance criteria.  Funded developmental centers
would be expected to apply competitively for funding to become full
centers by the end of their developmental period.
 
The AHCPR expects to commit up to $4 million in competitive awards for
MEDTEP Research Centers on Minority Populations in Fiscal Year 1992,
depending upon the availability of funds.
 
SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND
MINORITIES IN RESEARCH STUDY POPULATIONS
 
The AHCPR adheres to NIH and ADAMHA policy requiring applicants for
research grants to include minorities and women in study populations, so
that research findings can be of benefit to all.  This announcement
obviously addresses that policy with regard to minorities.  Additional
emphasis, however, should be placed on the need to include women of all
ages in studies of diseases, disorders, and conditions that affect them.
 
REVIEW PROCEDURES
 
Applications for these cooperative agreements will be evaluated by the
AHCPR grant peer review process.  Applications will initially be
assessed by AHCPR staff for responsiveness to this announcement.
Nonresponsive applications will be returned without further
consideration.
 
All responsive applications will undergo peer review for scientific
merit by an AHCPR review committee of non-Federal experts, and those
recommended for approval will also be reviewed by the National Advisory
Council for Health Care Policy, Research, and Evaluation.
 
ELIGIBILITY
 
Only nonprofit organizations are eligible to apply.  Foreign
institutions are not eligible to apply.
 
METHOD OF APPLYING
 
All applicants, except State and local governments, must use application
form PHS 398 (revised 10/88).  State and local governments may use form
PHS 5161, Application for Federal Assistance.  These forms are available
at most institutional business offices, from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892,
and from the AHCPR Office of Scientific Review at the address below.
 
The original and five copies of the completed application PHS 398 (or
the original and two copies of PHS 5161) are to be mailed or delivered
to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Completed applications must be received at the Division of Research
Grants on or before November 12.  Late applications will be returned
without review.
 
Potential applicants are requested to submit a letter of intent to Dr.
Miriam A. Kelly at the Rockville address below by August 12, 1991.  A
letter of intent is neither required nor binding, and does not enter
into the review of subsequent applications.  The letter of intent should
include the name(s) of the proposed Principal Investigator, principal
collaborators, and organization(s) involved.
 
Grant application materials may be obtained from:
 
Office of Scientific Review
Office of Planning and Resource Management
Agency for Health Care Policy and Research
Room 18A20, 5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3091
 
TIMETABLE
 
Letter of intent receipt date:  August 12, 1991
Application receipt date:  November 12, 1991
Initial (scientific) review date:  February 7, 1992
National Advisory Council meeting date:  May 1992
Earliest grant award and start date:  July-September 1992
 
For further program information and to request a copy of the RFA, write
or call:
 
Dr. Miriam A. Kelly
Health Scientist Administrator
Center for Medical Effectiveness Research
Agency for Health Care Policy and Research
6001 Montrose Road, Suite 704
Rockville, MD  20852
Telephone:  (301) 443-0782
 
For information on grants and business management aspects, write or
call:
 
Ralph L. Sloat
Chief, Grants Management Branch, OPRM
Agency for Health Care Policy and Research
5600 Fishers Lane, Room 18A27
Rockville, MD  20857
Telephone:  (301) 443-4033
 
Potential applicants should refer to the full RFA for more detailed
information, including criteria that will be used in the review of
applications.
 
The requirements of Executive Order 12372 are not applicable to the
AHCPR research grant program.  This program is described in the Catalog
of Federal Domestic Assistance number 93.180.  Funded projects will
operate under the PHS Grants Policy Statement (10/1/90 Edition) and 42
CFR, Part 67, Subpart A.
 
$$R2 END ***************************************************************
 
                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$P1 BEGIN PA-91-79 ****************************************************
 
ANOREXIA NERVOSA AND BULIMIA NERVOSA:  BASIC BRAIN, BEHAVIORAL, AND
CLINICAL STUDIES
 
PA:  PA-91-79
 
P.T. 34; K.W. 0404000, 0755030, 0785055, 1002030, 0745020, 0745027
 
National Institute of Mental Health
 
The National Institute of Mental Health (NIMH) invites applications that
use any of the available research grant mechanisms for the studies
relevant to the epidemiology, etiology, treatment, and prevention of
anorexia nervosa and bulimia nervosa.  The purpose of this announcement
is to place additional research emphasis on behavioral, clinical, and
central nervous system (CNS) aspects of ingestive behaviors and eating
disorders.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00473-0) or "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, D.C. 20042-9325 (telephone:
202-783-3238).
 
ELIGIBILITY
 
Applications may be submitted by any public or private, nonprofit or
for-profit, organizations such as universities, colleges hospitals,
laboratories, units of State or local governments, and eligible agencies
of the Federal Government.  Women and minority investigators are
encouraged to apply.
 
STUDY POPULATIONS
 
Applications for this grant are encouraged to include both women and
minorities in study populations, unless scientific evidence or other
justification for not including them is provided.  This requirement is
intended to ensure that the research findings will be of benefit to all
persons at risk of the disease, disorder, or condition under study.  For
the purpose of these policies, clinical research involves human studies
of etiology, treatment, diagnosis, prevention, or epidemiology of
diseases, disorders, or conditions, including but not limited to
clinical trials; and minorities include U.S. racial/ethnic minority
populations (specifically American Indians or Alaskan Natives,
Asian/Pacific Islanders, Blacks, and Hispanics).
 
The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
recognizes that it may not be feasible or appropriate in all clinical
research projects to include representation of the full array of U.S.
racial/ethnic minority populations.  However, applicants are urged to
assess carefully the feasibility of including the broadest possible
representation of minority groups.
 
Applications should include a description of the composition of the
proposed study population by gender and racial/ethnic group, and the
rationale for the numbers and kinds of people selected to participate.
This information should be included in the PHS form 398, Section 2, A-D
of the Research Plan and summarized in Section 2, E, Human Subjects.
 
Applications should incorporate in their study design gender and/or
minority representation appropriate to the scientific objectives of the
work proposed.  If representation of women or minorities in sufficient
numbers to permit assessment of differential effects is not feasible or
appropriate, the reasons for this must be explained and justified.  The
rationale may relate to the purpose of the research, the health of the
subjects, or other compelling circumstances (e.g.,if in the only subject
population available there is a disproportionate representation in terms
of age distribution, risk factors, incidence/prevalence, etc., of one
gender or minority/majority group).
 
If the required information is not contained within the application, the
review will be deferred until it is complete.  Peer reviewers will
address specifically whether the research plan in the application
conforms to these policies.  If gender and/or minority
representation/justification are judged to be inadequate, the reviewers
will consider this as a deficiency in assigning the priority score to
the application.
 
All applications/proposals for clinical research submitted to
ADAMHA/NIMH are required to address these policies.  ADAMHA/NIMH funding
components will not award grants that do not comply with these policies.
 
Applicants should also be aware that the Department of Health and Human
Services has regulations for the protection of human subjects and has
developed additional regulations for the protection of children.  A copy
of these regulations, 45 CFR 46, Protection of Human Subjects, is
available from the Office for Protection from Research Risks, National
Institutes of Health, Building 31, Room 5B59 Bethesda, Maryland 20892.
 
REVIEW PROCEDURES
 
Applications will be received under the usual PHS receipt and review
schedule.  Applications will be reviewed by an initial review group
(IRG) consisting primarily of non-Federal scientific and technical
experts.  Applications will receive a second-level review by the
appropriate Advisory Council based on policy considerations as well as
scientific merit.  Only applications recommended for approval by Council
may be considered for funding.
 
APPLICATION PROCEDURES
 
All research applicants must use the current version of the grant
application form PHS 398 (rev. 10/88).  Support may be requested for a
period of up to five years.  Annual awards will be made subject to
continued availability of funds and progress achieved.  A competing
supplemental application may be submitted during an approved period of
support to expand the scope or protocol of a project during the approved
period.  A competing continuation (i.e., renewal) application may be
submitted before the end of an approved period of support to continue a
project.
 
Grant funds may be used for expenses clearly related and necessary to
conduct research projects, including direct costs that can be
specifically identified with the project and allowable indirect costs of
the institution.  Funds may not be used to establish, add a component
to, or operate a treatment, rehabilitation, or prevention intervention
service program.  Support for research-related treatment,
rehabilitation, or prevention services and programs may be requested
only for costs required by the research.  These costs must be justified
in terms of research objectives, methods, and designs that promise to
yield generalizable knowledge and/or make significant contribution to
theoretical concepts.
 
MECHANISMS OF SUPPORT
 
Applications are requested under the traditional research project (RO1),
First Independent Research Support and Transition (FIRST) Award (R29),
small grant (RO3), institutional research training (T32), individual
fellowship (pre- and post-doctoral) (F series), career development (K
series), and program project (PO1) mechanisms.  In Fiscal Year 1990, it
is estimated that approximately $6 million was available to support 20
new and continuation grants on anorexia nervosa and bulimia nervosa.
However, the amount of funding will depend upon availability of funds
and program priorities at the time of the award.
 
INQUIRIES
 
Copies of this full announcement and additional information may be
obtained by contacting:
 
Susan J. Blumenthal, M.D, M.P.A.
Chief, Behavioral Medicine Program
Basic Prevention and Behavioral Medicine Research Branch
Division of Basic Brain and Behavior Sciences
National Institute of Mental Health
5600 Fishers Lane, Room 11C-06
Rockville, MD  20857
Telephone:  (301) 443-4337
 
Information on grants management issues may be obtained from:
 
Stephen Hudak
Chief, Grants Management Section
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-26
Rockville, MD  20857
Telephone:  (301) 443-4456
 
Awards are made under authority of Section 301 of the Public Health
Service Act (42 U.S.C. 241), and Catalog of Federal Domestic Assistance
93.242.
 
$$P1 END ***************************************************************
 
$$P2 BEGIN PA-91-80 ****************************************************
 
ANTICANCER MODEL DEVELOPMENT
 
PA:  PA-91-80
 
P.T. 34; K.W. 0755020, 0740020, 0755010, 0760075
 
National Cancer Institute
 
Application Receipt Dates:  October 1, February 1, and June 1
 
PURPOSE
 
Cancer treatments with greater specificity for cancer cells and less
toxicity for normal tissues are critically needed, especially for common
solid tumors that afflict the aging population.  As we enter an era of
increased understanding of the process of malignancy, opportunities are
emerging for defining and exploiting new molecular targets for the
discovery of more useful therapies.  With the development of a more
rational framework for the treatment of cancer, the ability to select
therapy for the individual patient should also improve.  The objective
of this announcement is to encourage research in the development of
models that will lead to the discovery and use of more effective
therapies.  Projects can be multidisciplinary as long as they are well
focused and meet the criteria described below.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas.  This program
announcement, Anticancer Model Development, is related to the priority
area of cancer.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017-001-00474-0) or "Healthy
People 2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
D.C. 20402-9325 (telephone 202-783-3238).
 
RESEARCH OBJECTIVES
 
The Division of Cancer Treatment of the National Cancer Institute is
seeking applications for traditional research grants (R01) with a focus
on models that will be more predictive of the clinical usefulness of new
anticancer treatments.  Examples of studies that might be addressed
include, but are not limited to:
 
  o  Rapid, resource efficient and cost-effective methods for evaluating
     new, potential anticancer agents.  For example, receptor-based
     screening techniques have been used effectively in other areas of
     medicine, such as in the search for drugs that lower blood
     cholesterol levels.  Assays that exploit recent discoveries in the
     molecular biology of tumor development, such as suppressor genes,
     are especially attractive.  Cell culture assays with cytotoxic
     endpoints that do not offer a distinct advantage over models in
     current use are not encouraged.  Applications that focus on
     screening or scale-up of existing procedures are not encouraged.
 
  o  Animal models that include the development of valid, surrogate
     endpoints for survival.  Transgenic animals, mice with a genetic
     predisposition to cancer, and severe combined immunodeficient
     (SCID) mice are examples of models used in other fields, such as
     carcinogenesis, differentiation, and tumor biology, that could be
     adapted for therapeutic studies.
 
  o  Models that will help select therapy for individual patients.  The
     expense and time for clinical trials could be reduced by selecting
     therapies with greater probability of effectiveness for a given
     patient.  Assays now being used to diagnose cancer, such as those
     involving the polymerase chain reaction, could be adapted for
     improved therapy selections.  Applications are encouraged with an
     emphasis on the development and evaluation of assays up to the
     point where they could be used in prospective clinical trials to
     validate the model.
 
Whichever model development approach is taken, applicants must provide a
rationale for how the model may identify improved therapies or may
enhance therapy selections and must outline a research plan involving a
testable hypothesis.  The nature of the model is limited only by the
creativity and ability of the applicant.
 
MECHANISM OF SUPPORT
 
This program will be supported through the NIH grant-in-aid mechanism
(R01).  This program announcement is a continuous announcement until
retracted.  Applications and future unsolicited competing renewal
applications will compete as research project applications with all
other investigator-initiated applications and be reviewed in a standing
Division of Research Grants study section.
 
Applications will compete for available funds with all other approved
applications within the assigned Institute.
 
ELIGIBILITY
 
Applications may be submitted by domestic and foreign, public or
private, nonprofit or for-profit, organizations such as universities,
colleges, hospitals, laboratories, units of State or local governments,
and eligible agencies of the Federal Government.  Applications from
minority individuals and women are encouraged.
 
REVIEW PROCEDURES
 
Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications will be reviewed for
scientific and technical merit by a study section of the Division of
Research Grants.  Following study section review, the applications will
receive a second-level review by the appropriate national advisory
council or board.
 
REVIEW CRITERIA
 
  o  Scientific merit and originality of proposed research.
 
  o  Appropriateness and adequacy of the experimental approach and
     methodology proposed to carry out the research.
 
  o  Qualifications of the Principal Investigator and support staff in
     regard to research experience, competence, commitment, and time
     availability.
 
  o  Adequacy of existing physical facilities and the research
     environment.
 
  o  Adequacy of proposed means for protecting against adverse effects
     upon humans, vertebrate animals, and the environment.
 
The review group will critically examine the requested budget and will
recommend an appropriate budget and period of support for each
application recommended for further consideration.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale for
its choice.  In addition, gender and racial/ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objective of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.
 
Applicants/offerors are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native Americans
(including American Indians or Alaskan Natives), Asian/Pacific
Islanders, Blacks, Hispanics).  The rationale for studies on single
minority population groups should be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.
 
The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every effort
should be made to include human tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.
 
If the required information is not contained within the application, the
application will be returned.
 
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in the study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.
 
All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.
 
METHOD OF APPLYING
 
Applications must be submitted on the grant application form PHS 398
(revised 10/88) and will be accepted at the standard application
deadlines.  Application kits are available at most institutional
business and grant/contract offices and may be obtained from the
Division of Research Grants, National Institutes of Health, Westwood
Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441.  The
title and number of this announcement must be typed in line 2 on the
face page of the application.
 
The original application and six signed exact photocopies must be
submitted or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
INQUIRIES
 
Inquiries about the objectives of this program announcement may be
addressed to:
 
Mary K. Wolpert, Ph.D.
Developmental Therapeutics Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Suite 832
Bethesda, MD  20892
Telephone:  (301) 496-8783
 
Inquiries of a budgetary or administrative nature should be directed to:
 
Ms. Barbara A. Fisher
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 29
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.395, Cancer Treatment Research.  Awards will be made under the
authority of Public Health Service Act, Title IV, Sections 301, 410, and
411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law
99-158, 42 USC 285a) and administered under PHS grant policies and
Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74.  This program
is not subject to the intergovernmental review requirements of Executive
Order 12372 or to Health System Agency review.  Awards will be
administered under Public Health Service grants policy as stated in the
PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000,
revised October 1, 1990.
 
$$P2 END ***************************************************************
 
                                   ERRATUM
 
$$E1 BEGIN R1 19910614 APPEND RFA AI-91-09 FULL ************************
 
PROGRAM PROJECTS ON AUTOIMMUNITY
 
RFA:  AI-91-09
 
P.T. 34; K.W. 0715015, 0745027, 0745070, 0710030
 
National Institute of Allergy and Infectious Diseases
 
The fourth paragraph under Mechanisms of Support of the full text online
version of the Request for Applications, "Program Projects on
Autoimmunity" (NIH Guide for Grants and Contracts, Vol. 20, No. 23, June
14, 1991) states that support will be limited to a maximum of four
years.  The maximum period of support is in error and is amended to
read:  Support for a program project in autoimmune mechanisms in disease
will be limited to a maximum of FIVE years.
 
$$E1 END ***************************************************************
 
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, Maryland 20816
 
                  FULL TEXT OF RFAs FOR ONLINE ACCESS